Principal Engineer, Quality

Baxter International Inc. • Milwaukee, WI

2d • $104,000 - $143,000

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter This is where your expertise helps people You are a problem solver. Complex projects or unexpected challenges are just opportunities to bring your considerable abilities to use. Whether working independently or with a trusted team, you are always ready to tackle a project and work hard to find solutions. Your talent is needed across a wide variety of industries. As a Principal Engineer, Quality, you have a wide array of career choices but are motivated by the opportunity to work in a company that supports innovation, professional development, and a purposeful mission. Your team We are a team of inquisitive individuals who embrace a collaborative environment to take on sophisticated challenges that meet the needs of our patients. We often need to change directions and respond to issues to avoid disruptions in our fast-paced manufacturing environment. Together, we build and maintain a positive work environment. Our Engineering Team is dedicated to quality. Delivering life-saving products is about getting them right, and our technical expertise and experience working in a manufacturing environment empower us to meet that challenge. When you join us, you will work with a team of committed individuals who trust each other to deliver on the tasks at hand. We support innovation and out-of-the-box thinking balanced with collaboration across functions and other teams. Our leadership understands the need for continuous education and provides opportunities for further development. As a Principal Engineer, Quality, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish. Here, you often have the flexibility to work independently. We provide opportunities for you to continue to learn through various training, conferences, certifications, and support for advanced degrees.

Requirements

• Bachelor’s degree in engineering or related field.
• 5+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense).
• Experience with development of embedded software, and stand-alone software as a medical device is required.
• Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization.
• Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus.
• Detail oriented with strong organizational and record keeping skills.
• Problem solving and root cause analysis skills.
• Systems Engineering knowledge, experience with complex multifunctional systems.
• Ability to facilitate cross-functional team meetings.
• Strong written and oral communications skills using English language; ability to succinctly and clearly describe complex issues in meaningful ways.
• Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts.
• Proactive and timely in execution of assigned tasks.
• Ability to be flexible and adaptable to changing priorities.
• Applicants must be authorized to work for any employer in the U.S.
• We are unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

• Experience with development of mechanical or electronic devices is a plus.
• Experience with manufacturing processes is a plus.
• ASQ or related quality certification is preferred.

Responsibilities

• Provide quality assurance support and guidance for product design activities including Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes.
• Ensure compilation and maintenance of product Design History Files.
• Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust.
• Review and approve Design Verification and Validation test plans, protocols and reports; guide the use of robust statistical techniques.
• Document traceability of requirements through design output and to design verification and/or design validation.
• Insist on early requirement maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs.
• Review intended use validation for non-product software and tools used in the development process.
• Actively participate with design teams on developing product Risk Management Files; ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards.
• Perform DHF audits of other products as an independent reviewer.
• Support external regulatory and customer audits.
• Support nonconformance and CAPA investigations and improvement action plans.
• Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, aspiring for a world-class Product Development Process.

Benefits

• Baxter offers comprehensive compensation and benefits packages for eligible roles.
• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level